Ana M. Bertoli

SAT0488 Tuberculosis in A Registry of Rheumatic Patients Treated with Biological Drugs

Background Biologic therapies (bDMARDs) have improved the treatment of rheumatic diseases; however, the risk of tuberculosis (TB) infection or reactivation in patients treated with this drug class remains a concern. Objectives We investigated the clinical characteristics and prognostic factors of TB in an Argentine registry of rheumatic diseases patients treated with bDMARDS. Methods Database included demographics of patients, type and duration of treatments and clinical information of adverse events. A control group was included for comparison consisting of patients not treated with bDMARDs but similar demographics. Values are expressed as mean±standard deviation, median (ranges), and frequencies (percentages), as appropriate. Multivariate logistic regression analysis was used to identify variables associated with the occurrence of TB; OR and 95% CI were calculated by exponentiation of regression coefficients. Results As of January 2016, 3483 patients, 4762 treatments and 2580 adverse events were studied. Mean age 56.1±15,7 years; 2748 (78.9%) patients were women. Initial treatments were 1472 (42.3) bDMARD vs. 2011 (57.7) non-bDMARD. Main diagnosis: Rheumatoid arthritis (RA) 2706 (77.7), Psoriatic arthritis (PsA) 293 (8.4), juvenile idiopathic arthritis (JIA) and lupus with 117 (3.36) each. Of 4762 treatments, most frequent biological drugs were etanercept 119 (25,1), adalimumab 626 (13,2), and abatacept with 282 (5.9). Of 3483 patients, 18 (0.5) presented TB as an adverse event, their mean age was 52.9±2.8; 16 (88.9) had AR and 2 (11.1) had PsA; 16 (88.9) had initially received bDMARD vs. 2 (11.1) who had received non- bDMARD treatments. PPD test was performed in 2002/2883 (69.4) bDMARD treatments vs. 372/1879 (19.8%) non-bDMARD treatments, with 126 (6.3) vs 35 (9.4) positive tests, respectively. Median time from treatment commencement to TB was 15.1 (range 1.6–137.5) months. Treatments during which, TB was diagnosed were etanercept 5 (27.8), adalimumab 4 (22.2), non-bDMARD 3 (16.7), abatacept and infliximab with 2 (11.1) each and tocilizumab 1 (5.6), the distribution was not significantly different (Table 1). The risk of developing TB was higher in patients whose first treatment was bDMARDs (OR 5.6 95%CI 1.3–24.3). Conclusions A higher frequency of TB was seen in patients treated with bDMARDs; however, results should be interpreted cautiously because of registries inherent limitations. Disclosure of Interest None declared

AB1097 The Impact of Systemic Lupus Erythematosus on Work Productivity: Data from Patients from the Province of Cordoba, Argentina

Background Since SLE tends to occur during the productive years of life, the cost of the disease derives not only from direct health expenditures but also from the impact the disease has on work productivity. Objectives To describe the impact of SLE on work productivity and to assess the factors influencing this outcome measure. Methods We studied 225 patients (1987 ACR criteria), age ≥16 years. Work productivity was assessed with the WPAI:Specific Health Problem for SLE. The WPAI yeilds four scores: % work time missed, % of impairment at work, % of overall work impairment and % of non-work related activity impairment. The relationship between socioeconomic-demographic, self-reported quality of life (as per the Lupus PRO), clinical data [clinical manifestations, diagnostic criteria (1987 ACR criteria), disease activity (SELENA-SLEDAI), damage (SLICC Damage Index), co-morbidities (Charlson Index)] and the four scores of the WPAI was examined with the Man-Whitney U test and Spearmans Rho test. Variables with p≤0.10 in these analyses were then entered in a multivariable linear regression with each score of the WPAI as the dependent variable. Results Patients were predominantly females (89%) and they had a median (IQR) age at diagnosis of 26.0 (16.0) years. Median (IQR) disease duration was 96.0 (144.0) months. Median (IQR) percentage of work time missed was 0.0 (25.0)%, of impairment at work was 10.0 (56.0)%, of overall work impairment 0.0 (56.0)% and of activity impairment 40.0 (60.0)%. Variables significant in both, the univariable and multivariable analyses, are shown in Table below Conclusions While work productivity is not largely affected in this sample of patients, non-work related activities seems to have a much greater impact in SLE. Patients with a higher disease activity and number of co-morbidities and a lower self-perceived quality of life are at higher risk for work productivity impairment Disclosure of Interest None declared

FRI0560 Argentinian register of biologics treatments (biobadasar). results

Background It´s known that LatinAmerican countries have different prevalence of infectious diseases and so it´s important to assess the incidence of adverse events using biologics to compare in the future with results from other registries Objectives The objective is to communicate data from BIOBADASAR, Argentine Registry of Adverse Events (AE) caused by the use of biological agents in Rheumatology Methods All Patients with rheumatic diseases that requires biologic treatment and a control patient, not treated with biological agents, were included in the database from 31 sites participating along Argentine. Three data areas were studied: patient features, treatment assigned and adverse events(AE). The BIOBADASER database was given from the Spanish Society of Rheumatology for our use. Loading data began in August 2010 and closed for this analysis, in July 2012. The Infostat software was used to stadistic analysis. Incident rates, relative risk and person/year incidence for adverse events were calculated Results 1508 patients were incorporated with 1909 treatments. 1197 women (79%) and 311 men(21%). The mean age was 55 years (range 3 to 90). 1107 patients (58%) were treated with biologic agents (cases) and 802 (42%) were controls. 1199 patients had rheumatoid arthritis (80%) and 137 psoriatic arthritis (9%) among the main diagnoses. The median time of progression of disease was 9 years. The most frequent biologic used was etanercept (50%of treatments) with a survival to treatment in months of 28 followed by adalimumab with 22.7%of the treatments and a survival in months of 26. The most frequent cause of treatment interruption for the cases was AE (41%) followed by inefficacy (33%). The incidence of serious adverse events was 28/1000ptesyears in the biologic group vs 3/1000 patient year in the control group (RR 6.8;CI 4.1-11.2;p<0,05). The most common AE was infection with a RR 5.49 (CI 4,1-7.1;p<0,05). Within infections pneumonia had a RR of 30 (CI 7.1-14.9; p<0,05 ), herpes zoster RR 5.29 (CI 1.7-16; p<0,05) and cellulitis with a RR 5.5 (CI 1,5-19,8 p<0,05). Tumoral diseases had a RR 3.32 (CI 1.5-7.0; p<0,05). There was 3 cases of Tuberculosis in the biological group and 1 in the control group (non significant difference) Conclusions This is the BIOBADASAR report showing the reality of biological treatments in Argentina. The patients of LatinAmerican countries could show some differences with other countries using the same treatments due to differences in regional diseases, vaccination or tolerability to pathogen agents Acknowledgements María Laura Kozono. Monitora Sociedad Argentina de Reumatología Disclosure of Interest None Declared